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Table 6 Safety of anti-IL agents (anakinra, canakinumab, and rilonacept) in refractory patients with AOSD: data from retrospective observational studies, nationwide survey, and clinical trials

From: Management of adult-onset Still’s disease with interleukin-1 inhibitors: evidence- and consensus-based statements by a panel of Italian experts

StudyDesignStudy drugAdverse event, no. of patients
Injection site reactions (ISR)
 Naumann et al. [62]ROAnakinra2/8 (25%)
 Laskari et al. [63]ROAnakinra5/25 (20%)
 Gerfaud-Valentine et al. [68]ROAnakinra“Some”/6
 Cavalli et al. [70]ROAnakinra2/20 (10%)
 Colafrancesco et al. [76]ROAnakinra28/140 (20%)
 Giampietro et al. [66]Nationwide surveyAnakinra“Some”/28
 Ortiz-Sanjuan et al. [71]Nationwide surveyAnakinra6/41 (14.6%)
 Nordstrom et al. [18]Clinical trial (RCT)Anakinra8/12 (66.6%)
Diffuse cutaneous reactions (rash/urticaria/eczema)
 Laskari et al. [63]ROAnakinra3/25 (12%)
 Quartuccio et al. [65]ROAnakinra3/10 (30%)
 Toz et al. (abstract) [75]ROAnakinra1/7 (14.2%)
 Colafrancesco et al. [76]ROAnakinra12/140 (8.5%)
 Lequerre et al. [60]Nationwide surveyAnakinra2/15 (13.3%)
 Ortiz-Sanjuan et al. [71]Nationwide surveyAnakinra2/41 (4.8%)
 Feist et al. [33]Clinical trial (post hoc analysis)Canakinumab13/31 (41.9%)
Infections (mild and severe)
 Laskari et al. [63]ROAnakinra6/25 mild (24%); 1/25 severe (4%)
 Cavalli et al. [70]ROAnakinra2/20 mild (10%)
 Colafrancesco et al. [76]ROAnakinra4/140 mild (2.8%); 2/140 severe (1.4%)
 Lequerre et al. [60]Nationwide surveyAnakinra4/15 mild (26.6%); 1/15 severe (6.6%)
 Ortiz-Sanjuan et al. [71]Nationwide surveyAnakinra3/41 mild (7.3%); 2/41 severe (4.8%)
 Rossi-Semerano et al. [73]Nationwide surveyAnakinra2/35 severe (5.7%)
 Henderson et al. [61]Clinical trial (POL dose escalation)Rilonacept2/5 severe (40%)
 Feist et al. [33]Clinical trial (post hoc analysis)Canakinumab21/31 mild (67.7%); 2/31 severe (6.4%)
Other adverse events
 Quartuccio et al. [65]ROAnakinra2/10 (20%) (thrombocytopenia)
 Colafrancesco et al. [76]ROAnakinra2/140 (1.4%) (thrombocytopenia) 1/140 (0.7%) (leukopenia) 1/140 (0.7%) (lymphoproliferative disorders)
 Lequerre et al. [60]Nationwide surveyAnakinra1/15 (6.6%) (Hip osteonecrosis)
 Ortiz-Sanjuan et al. [71]Nationwide surveyAnakinra3/41 (7.3%) (leukopenia) 1/41 (2.4%) (myopathy)
 Feist et al. [33]Clinical trial (post hoc analysis)Canakinumab18/31 (58%) (GI disorders) 10/31 (32.2%) (respiratory)
Macrophage activation syndrome
 Colafrancesco et al. [76]ROAnakinra6/140 (4.2%)
 Colafrancesco et al. [76]ROCanakinumab1/4 (25%)
 Rossi-Semerano et al. [73]Nationwide surveyAnakinra1/35 (2.8%)
 Henderson et al. [61]Clinical trial (POL dose escalation)Rilonacept1/5 (20%)
 Feist et al. [33]Clinical trial (post hoc analysis)Canakinumab3/31 (9.6%)
  1. AOSD adult-onset Still’s disease, POL prospective open-label, RCT randomized controlled trial, RO retrospective observational